Last updated: 11/07/2018 01:42:37

Fluticasone Furoate/GW642444 Inhalation Powder Long-Term Safety Study

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GSK study ID
106839
See study documents
Clinicaltrials.gov ID
NCT01018186
See results summary
EudraCT ID
2009-01205-20
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Randomized, Double-Blind, Double Dummy, Active Comparator, Parallel Group, Multicenter Study to Evaluate the Safety of Once-Daily Fluticasone Furoate/GW642444 Inhalation Powder for 52 Weeks in Adolescent and Adult Subjects with Asthma
Trial description: The purpose of this study is to evaluate the long-term safety of fluticasone furoate/GW642444
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Number of participants with any adverse event (AE) or serious adverse event (SAE) during the Treatment Period

Timeframe: From the start of study medication until Visit 11 (Week 52)/Early Withdrawal

Number of participants with severe asthma exacerbations during the Treatment Period

Timeframe: From the start of study medication until Visit 11 (Week 52)/Early Withdrawal

Change from Baseline in albumin and total protein at Week 12, Week 28, and Week 52/Early Withdrawal

Timeframe: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal

Change from Baseline in alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatine kinase (CK), and gamma glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal

Timeframe: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal

Change from Baseline in direct bilirubin, indirect bilirubin, total bilirubin, and creatinine at Week 12, Week 28, and Week 52/Early Withdrawal

Timeframe: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal

Change from Baseline in chloride, carbon dioxide content/bicarbonate, glucose, potassium, sodium, and urea/blood urea nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal

Timeframe: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal

Change from Baseline in the percentage of basophils, eosinophils, hematocrit, lymphocytes, monocytes, and segmented neutrophils in the blood at Week 12, Week 28, and Week 52/Early Withdrawal

Timeframe: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal

Change from Baseline in eosinophil count, total absolute neutrophil count (ANC), platelet count, and white blood cell (WBC) count at Week 12, Week 28, and Week 52/Early Withdrawal

Timeframe: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal

Change from Baseline in hematocrit at Week 12, Week 28, and Week 52/Early Withdrawal

Timeframe: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal

Change from Baseline in hemoglobin at Week 12, Week 28, and Week 52/Early Withdrawal

Timeframe: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal

Number of participants with the indicated shift from Baseline to high, normal or no change, and low post-Baseline values for urinary cortisol excretion

Timeframe: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal

Ratio of 24-hour urinary cortisol excretion at Week 12 to Baseline

Timeframe: Baseline and Week 12

Ratio of 24-hour urinary cortisol excretion at Week 28 to Baseline

Timeframe: Baseline and Week 28

Ratio of 24-hour urinary cortisol excretion at Week 52 to Baseline

Timeframe: Baseline and Week 52

Number of participants with evidence of oral candidiasis at any time post-Baseline

Timeframe: From Baseline until Visit 11/Early Withdrawal (52 weeks)

Maximum change from Baseline in systolic blood pressure (SBP) and minimum change from Baseline in diastolic blood pressure (DBP)

Timeframe: From Baseline until Visit 11/Early Withdrawal (52 weeks)

Maximum change from Baseline in pulse rate

Timeframe: From Baseline until Visit 11/Early Withdrawal (52 weeks)

Number of participants with the indicated change from Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52

Timeframe: Baseline; Week 28, and Week 52

Number of participants with the indicated change from Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52

Timeframe: Baseline; Week 28 and Week 52

Change from Baseline in horizontal cup-to-disc ratio at Week 28 and Week 52

Timeframe: Baseline; Week 28 and Week 52

Number of participants with the indicated change from Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52

Timeframe: Baseline; Week 28 and Week 52

Change from Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52

Timeframe: Baseline; Week 28 and Week 52

Change from Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52

Timeframe: Baseline; Week 28 and Week 52

Change from Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) visual acuity at Week 28 and Week 52

Timeframe: Baseline; Week 28 and Week 52

Maximum change from Baseline in the QT interval using Bazett’s correction (QTcB) and QT interval using Fridericia’s correction (QTcF)

Timeframe: Baseline; Week 2, Week 12, Week 28, and Week 52/Early Withdrawal

Mean 24 hour Holter heart rate for participants with at least 16 hours of recorded data

Timeframe: 0-24 hours at Screening, Day 1, Week 28, and Week 52

Maximum 24 hour Holter heart rate for participants with at least 16 hours of recorded data

Timeframe: 0-24 hours at Screening, Day 1, Week 28, and Week 52

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Fluticasone Furoate/GW642444
  • Drug: Fluticasone propionate
    • Enrollment:
    503
    Primary completion date:
    2011-12-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Busse WW, O’Byrne PM, Bleecker ER, Lötvall J, Woodcock A, Andersen L, Hicks W, Crawford J, Jacques L, Apoux L, Bateman ED. Safety and tolerability of the novel inhaled corticosteroid fluticasone furoate in combination with the beta2 agonist vilanterol administered once daily for 52 weeks in patients >=12 years old with asthma: a randomised trial. Thorax. 2013;68(6):513-20.
    Medical condition
    Asthma
    Product
    fluticasone furoate, fluticasone furoate/vilanterol, fluticasone propionate, vilanterol
    Collaborators
    Not applicable
    Study date(s)
    October 2009 to May 2011
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    No
    • Clinical diagnosis of asthma
    • Reversibility FEV1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol
    • History of life threatening asthma
    • Respiratory infection or oral candidiasis
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Clinical diagnosis of asthma
    • Reversibility FEV1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol
    • FEV1 greater than or equal to fifty percent of predicted
    • Currently using moderate to high dose inhaled corticosteroid therapy
    Exclusion criteria:
    • History of life threatening asthma
    • Respiratory infection or oral candidiasis
    • Asthma exacerbation
    • Uncontrolled disease or clinical abnormality
    • Allergies
    • Taking another investigational medication or prohibited medication

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Huntington Beach, California, United States, 92647
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bangkok, Thailand, 10400
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bangkok, Thailand, 10330
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Chiangmai, Thailand, 50200
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10717
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 10365
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 41 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2011-12-05
    Actual study completion date
    2011-12-05

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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